The United States Pharmacopoeia (USP) general chapter <1085> provides general guidance for the assessment of pharmaceutical materials, components and products. USP general Chapter <85>, Bacterial Endotoxins, and European Pharmacopoeia (EP) general chapter 2.6.14, Bacterial Endotoxins, provide method guidance to detect and quantify the levels of bacterial endotoxins that may be present in or on the sample.
Our Minnesota laboratory utilizes the kinetic photometric methods (chromogenic / turbidimetric). Our Puerto Rico location has invested in the Endosafe Nexgen-MCS automated cartridge technology from Charles River. This investment allows a higher throughput with reduced risk and improved data integrity.
The USP general chapter <1085> was updated to provide additional guidance in December of 2019. The updated guidance re-establishes the need for preparatory testing to verify that the sample matrix does not inhibit nor enhance (I/E) the instrument response to provide a biased test result. The guidance offers considerations for different products, based upon the product type and manufacturing processes.
Pace Analytical Life Sciences brings years of experience performing bacterial endotoxins testing on many drug substances, drug products and implantable medical devices. We bring the highest level of quality and attention to detail to our clients to assure that our endotoxin testing services will be successfully executed. Contact us to discuss your challenging needs or to learn more about our procedures and potential solutions.
We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.